My story of being a hypochondriac, an MS patient, and a guinea pig.
NOTE: This blog is no longer actively posting. Please Join us over at http://www.partnersinresearch.org or find us on Facebook at
http://www.facebook.com/partersinresearch.org

Pages

Saturday, August 11, 2007

A hypochondriac joins a clinical trial

So I'm entering a clinical trial. Visions of being stuck in a tiny cage with one of those exercise wheels comes to mind. Lab rat. But even though I enter the study with some amount of trepidation, I am still excited.

This is cutting edge stuff. Historic, actually, in the field of Multiple Sclerosis treatments for until now there has been no disease modifying medication that didn't involve needles and regular injections. Fingolimod (nice name, eh?) is one of the current drugs being studied that will, if approved by the FDA, change the face of MS treatment the world over. No more dreaded needles, injection site reactions, dents from Copaxone, red patches from Avonex, etc. People who are newly diagnosed will no longer have to come to grips with being told they could slow progression by stabbing themselves on a regular basis when they are just beginning to suffer the shock of wrapping their minds around the fact that they have a incurable disease. That's more cruelty than anyone should have to endure.... "hey, you have an incurable, debilitating disease that could possibly cripple you, but if you take this needle and stab yourself once a ___ (insert day, week, month depending on your drug of choice) then you might slow it down some."

I pretty much fell into this trial quite by accident. I was flying solo on the MS path. My neuro for 6 years had the unfortunate luck to suffer a stroke himself and was put out of commission. I was left doctorless and spent 2 years self-diagnosing and treating my MS. The only neurologists in my dinky town either wouldn't accept new patients, wouldn't accept MS patients, or wouldn't take Medicaid or some combination thereof. I was constantly stressed about it, and in hindsight it's really no wonder that I was having a relapse every 3-4 months. Stress can do that to you.

Finally my PCP got proactive on my behalf (since he realized I was basically clueless and had developed a defeatist's attitude) and got me an appointment with Dr. Kantor at the Comprehensive MS Center at Shands Hospital in Jacksonville. At that first visit we discussed changing my disease modifying drug from Copaxone (the only one I'd ever taken) to one of the others which are all interferons. I had a lot of apprehension over this change due to my fears of the side effects with any interferon. I have heard that they make you sick with flu-like symptoms, can cause depression, and can make you suicidal.

Dr. Kantor had a better idea. He just happens to be the lead investigator for the MS Center's research program which is working in conjunction with Novartis Pharmaceuticals to investigate the safety and efficacy of FTY-720. Once I said yes, the whirlwind intensive testing-to-make-sure-I-can-participate phase began.

I had an MRI of my brain (which wasn't so bad -- I had to have my head in that birdcage thing, but at least I got the 4 foot tube instead of the 8 foot tube!! My medically necessary Xanax for claustrophobia instantly became recreational upon seeing the 4 foot tube. (photo not of actual MRI machine I was in, but you get the idea).

Then I had a CT of my chest to make sure there's no existing lung disease. I also had an EKG and they drew a LOT of blood.

The next visit was the one I was worried about. I really was scared of the eye exam most of all. Due to a couple people developing macular edema in previous studies of Fingolimod, the informed consent detailed a ophthalmology visit that sounded more invasive and maybe even painful. Turns out it wasn't so bad after all. I got my eyes dilated and checked for pressure, then she shined some really REALLY bright light in them to look around and I swear I saw spots three hours later from that.

Then it was off to get an OCT which I'm guessing was an optical cat scan. I had to look in this box (like the one shown in the picture) while they had me stare at a green dot on a field of red and showed me a light show. Hard to describe, but I'm guessing they got more out of it than I did. Then I had a Humphrey's test. That's a field of vision test where you look into this bowl and stare at a spot in the center while little lights flash all around one after the other. You have to press a button (like answering on Jeopardy!)every time you see one flash. (See blurry image below of a Humphrey's testing machine.)So, with most of the testing out of the way, I have only 2 more appointments before I partake of the medication. The EDSS (Expanded Disability Status Scale) is next and is done in 2 parts (2 different days). And I have to wear a Holter Monitor for 24 hours.

Randomization (the fancy name they give the big day of getting my first dose) is set for August 20th at 9 a.m. rain or shine. It's an all day event because I have to have my blood pressure and heart rate monitored hourly. Seems Fingolimod can lower your heart rate by up to 25 beats per minute upon administration of the first dose. Fortunately, it won't do it again unless the meds are stopped for 8 days or longer and restarted.

In this study, I have a 2/3 chance of getting the Fingolimod (FTY-720) as there are 2 groups getting it (one at 1.25 mg and another at 0.5 mg) pitted against an already approved MS disease modifying drug (Avonex). I'm crossing all my fingers and toes that I get one of the doses of Fingolimod because I'm not real thrilled about starting an interferon. :-( But, hey, it's better than having a possible placebo and finding out I was on NOTHING after 6 months or a year.

I have already nearly gotten myself kicked out of the trial because when my labs came back about my blood work I found out I have low platelet count and a high MCV. I got on the internet and did some investigating and decided I have Lupus. My neuro was questioning why this was coming up all of a sudden with no prior mention of Lupus. He thought I was trying to chicken out of the study and said "no problem, we'll just take you out of the study"... and I'm begging "no!! NO!! please!! I don't want to get out -- I was just worried, because of what I had read, and what others have told me." LOL He told me to stay off the internet, but he let me stay in the study. heh... guess I'm not staying off the internet, am I? Oh well... he's never met a hypochondriac with quite the imagination I have. Wait until I get that first pill! I have the doctor's pager number. (evil grin)

Dr. Kantor came to St. Petersburg Florida and gave a lecture recently. It was very informative and I really enjoyed it. I wondered who was the first documented case of a person with MS. Dr. Kantor told us it was a young girl who they made a Saint because she seemed cured after a long illness with various symtoms that were consistant with MS. Saint Lidwina was her name.

I start my Fingolimod Avonex study on August 21st. I'll keep you posted. See you on the message boards.

Knowing you are anxious about the 20th, rest assured that all fingers and toes are crossed in Kansas for you, my friend. Your strength and positive attitude speak volumes for those who aren't able to express their hopes and fears of living with MS. Hugs!

Disclaimer

This blog, gilenya.blogspot.com, is not affiliated with Novartis Pharmaceutical Corp. or its branded product, GILENYA (R). The content herein is solely the opinion of the blogger.

Furthermore, I am not a medical professional and the content herein is presented as solely my opinion, and should not be considered as medical advice.

Everyone's experience is different and I am not suggesting that my experience is typical.

Keep an open dialog with your doctor and be sure to discuss any questions you have with him/her. Never act on anything you may have read on the internet -- whether on this blog or elsewhere -- without first discussing it with a qualified healthcare provider.